Investigational oral formulation of hydrocodone, acetaminophen shows efficacy in phase 3 acute pain trial

An investigational extended-release oral formulation of hydrocodone and acetaminophen for treatment of moderate to moderately severe acute pain was more effective than placebo at providing rapid and consistent pain relief in patients 48 hours post-surgery, according to data presented at PAINWeek 2014 in Las Vegas.

A phase 3 multicenter, randomized, double-blind, placebo controlled, parallel-arm study study of MNK-155 (Mallinckrodt) compared the efficacy and safety of MNK-155 and placebo in 403 patients with moderate to moderately severe acute pain following a unilateral first metatarsal bunionectomy.

Patients received a single 3-tablet loading dose of MNK-155 (7.5 mg hydrocodone and 325 mg acetaminophen tablets; 22.5 mg /975 mg total dose), followed by of 2 tablets every 12 hours (15 mg /650 mg total dose) over 48 hours or placebo. Rescue ibuprofen up to 400 mg every 4 hours was allowed for both the MNK-155 and placebo arms.

The primary end point was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48). Secondary measures included: Cumulative SPID at 0−4, 0−8, 0−12, 0−24, and 0−36 hours; mean PID beginning 15 minutes after dosing, mean total pain relief for the time periods 0−4, 0−8, 0−12, 0−24, 0−36, and 0−48 hours; and time to perceptible, confirmed, and meaningful pain relief.

“If approved, MNK-155 would provide patients with moderate to moderately severe acute pain, such as those who undergo surgery in hospitals and other acute care settings, with rapid and sustained pain relief, giving these patients an option that allows for less frequent [twice daily] dosing,” said Anthony Lassiter, vice president, global pharmacovigilance and medical information, Mallinckrodt.